IgA nephropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Part I (1) Age 18~75 years old, gender and ethnicity are not limited; (2) Pathologic diagnosis of IgA nephropathy; (3) Renal function: stage 1-2; (4) TCM syndrome differentiation is consistent with the syndrome of lung and spleen qi deficiency, and both water and dampness and stasis; (5) Pathological indicators: Lee's grade II or above, or Pathological changes like segmental or glomerular sclerosis, renal tubular atrophy, and interstitial fibers can be seen. (6) 24-hour urine protein quantification = 2.5g. Part II (1) Age 18~75 years old, gender and ethnicity are not limited; (2) Pathologic diagnosis of IgA nephropathy; (3) Renal function: stage 3; (4) TCM syndrome differentiation is consistent with liver and kidney yin deficiency syndrome, dampness and heat, and blood stasis; (5) Pathological indicators: Lee's grade II or above, or pathological segmental or glomerular sclerosis, renal tubular atrophy, and interstitial fibers can be seen Pathological changes predominantly lesions. (6) 24-hour urine protein quantification = 2.5g. Part III (1) Age 18~75 years old, gender and ethnicity are not limited; (2) Pathologic diagnosis of IgA nephropathy; (3) Renal function: stage 4-5; (4) The syndrome differentiation of traditional Chinese medicine is consistent with the spleen and kidney yang deficiency syndrome, which is both cold and damp and stasis; (5) Pathological indicators: Lee's grade II or above, or pathological segmental or glomerular sclerosis, renal tubular atrophy, and interstitial fibers can be seen Pathological changes predominantly lesions.
Exclusion criteria
Exclusion criteria: (1) Received immunosuppressants and cytotoxic drugs in the past 3 months > 4 weeks; (2) Have received glucocorticoids (prednisone or prednisolone) at a dose of 20mg/d >> for 4 weeks in the past 3 months; (3) Patients with acute or rapidly progressive nephritis and patients with acute progressive IgA nephropathy; (4) Patients with active hepatitis B and abnormal aminotransferases in continuous liver function tests; (5) Patients with malignant tumors or history of malignant tumors, HIV infection, psychiatric disorders, acute central nervous system diseases, severe gastrointestinal diseases and contraindications to the use of glucocorticoids; (6) Patients with abnormal glucose metabolism and fasting blood glucose > 6.2mmol/L; (7) Pregnant or lactating women; (8) Investigators who are undergoing other clinical trials; (9) Patients with life-threatening complications, such as severe infection or serious diseases and dysfunction of other organs. (10) IgA disease caused by secondary factors such as allergic purpura nephritis, chronic alcoholic liver disease, ankylosing spondylitis, psoriasis, lupus nephritis, etc.;Patients with serious primary diseases such as heart, brain, liver and hematopoietic system;patients with mental illness;patients allergy to the test drug or intolerant of known adverse reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein quantification; | — |
Countries
China
Contacts
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine